NCT05266573

Brief Summary

The purpose of this study is to evaluate the effectiveness of a structured and progressive task-oriented, community based exercise program for older adults who have limitations in mobility and examine whether improvements in mobility and quality of life would be seen following completion at 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

February 14, 2022

Last Update Submit

February 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in 6 Minute Walk Test

    A submaximal exercise test used to assess aerobic capacity and cardiorespiratory fitness.

    Baseline to 6 months

Secondary Outcomes (3)

  • Change in Activities Balance Confidence Scale

    Baseline to 6 months

  • Change in Short Form 36

    Baseline to 6 months

  • Change in Gait Speed

    Baseline to 6 months

Study Arms (1)

Exercise Participants with Limited Mobility

EXPERIMENTAL

The task oriented exercise program consists of 45 to 60 minutes of group exercise sessions with the following components: Warm Up: Walking which is progressively increased from 6 to 15 minutes. Dual task activity is introduced as tolerated by the participants. Participants are able to utilize assistive devices and there were additional supports provided. Stretching, Strengthening and Balance Activities: Gradual progression of activities and repetitions for 30 minutes that are tailored by the exercise instructor to each participant. Exercises are led by the trainer and performed at the balance bar, in a chair, or in standing. Task oriented activities included items such as: weight shifting, forward/backward/side stepping, squats, forward/backward/side leg raises, toe raises, seated trunk rotations, sit to stand, forward trunk bending, arm rotations, and marching. Walk/Obstacle Course: The final 6 to 15 minutes included "challenged walking" through an obstacle course.

Other: Exercise Group

Interventions

The exercise program is led by an individual who has a background in exercise physiology and is trained by the Physical Therapist. The task oriented exercise program consists of 45 to 60 minutes of group exercise sessions with the following components: warm-up period (dual task activity and walking progressively), stretching/strengthening/balance (gradual progression of activities and repetitions for 30 minutes), and obstacle course (6 to 15 minutes of obstacle course and challenged walking).

Exercise Participants with Limited Mobility

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Limitations in mobility as evidenced by 6 Minute Walk Test score of \< 499 meters
  • Motivation to participate in an exercise program

You may not qualify if:

  • unable to follow commands
  • unstable cardiac status
  • greater than minimal assist for mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44504, United States

Location

Related Publications (10)

  • Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.

    PMID: 17762378BACKGROUND
  • Alqahtani BA, Sparto PJ, Whitney SL, Greenspan SL, Perera S, VanSwearingen J, Brach JS. Effect of Community-Based Group Exercise Interventions on Standing Balance and Strength in Independent Living Older Adults. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E7-E15. doi: 10.1519/JPT.0000000000000221.

    PMID: 31592997BACKGROUND
  • Rensink M, Schuurmans M, Lindeman E, Hafsteinsdottir T. Task-oriented training in rehabilitation after stroke: systematic review. J Adv Nurs. 2009 Apr;65(4):737-54. doi: 10.1111/j.1365-2648.2008.04925.x. Epub 2009 Feb 9.

    PMID: 19228241BACKGROUND
  • Tisher K, Mann K, VanDyke S, Johansson C, Vallabhajosula S. Functional measures show improvements after a home exercise program following supervised balance training in older adults with elevated fall risk. Physiother Theory Pract. 2019 Apr;35(4):305-317. doi: 10.1080/09593985.2018.1444116. Epub 2018 Mar 5.

    PMID: 29505321BACKGROUND
  • Skrastins O, Tsotsos S, Aqeel H, Qiang A, Renton J, Howe JA, Tee A, Moller J, Salbach NM. Fitness coordinators' and fitness instructors' perspectives on implementing a task-oriented community exercise program within a healthcare-recreation partnership for people with balance and mobility limitations: a qualitative study. Disabil Rehabil. 2020 Sep;42(19):2687-2695. doi: 10.1080/09638288.2019.1570357. Epub 2019 Feb 10.

    PMID: 30739500BACKGROUND
  • Salbach NM, Howe JA, Brunton K, Salisbury K, Bodiam L. Partnering to increase access to community exercise programs for people with stroke, acquired brain injury, and multiple sclerosis. J Phys Act Health. 2014 May;11(4):838-45. doi: 10.1123/jpah.2012-0183. Epub 2013 May 13.

    PMID: 23676952BACKGROUND
  • Salbach NM, Howe JA, Baldry D, Merali S, Munce SEP. Considerations for expanding community exercise programs incorporating a healthcare-recreation partnership for people with balance and mobility limitations: a mixed methods evaluation. BMC Res Notes. 2018 Apr 2;11(1):214. doi: 10.1186/s13104-018-3313-x.

    PMID: 29609662BACKGROUND
  • Merali S, Cameron JI, Barclay R, Salbach NM. Characterising community exercise programmes delivered by fitness instructors for people with neurological conditions: a scoping review. Health Soc Care Community. 2016 Nov;24(6):e101-e116. doi: 10.1111/hsc.12282. Epub 2015 Oct 7.

    PMID: 26445890BACKGROUND
  • Chompoonimit A, Nualnetr N. The impact of task-oriented client-centered training on individuals with spinal cord injury in the community. Spinal Cord. 2016 Oct;54(10):849-854. doi: 10.1038/sc.2015.237. Epub 2016 Jan 12.

    PMID: 26754477BACKGROUND
  • Bird ML, Hill K, Ball M, Williams AD. Effects of resistance- and flexibility-exercise interventions on balance and related measures in older adults. J Aging Phys Act. 2009 Oct;17(4):444-54. doi: 10.1123/japa.17.4.444.

    PMID: 19940323BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy Landgraff, PhD

    Youngstown State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 4, 2022

Study Start

January 8, 2015

Primary Completion

March 10, 2017

Study Completion

March 10, 2017

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations